MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-10-31 for FORMALIN 10% 5 GALLON * 575A-5 GAL manufactured by Medical Chemical Corp.
[331669]
Informed that a formalin spill had occurred in pacu utility room. The nurse immediately placed first can of neutralizer on spill. Fumes were strong. Spill cart arrived with environmental services lead. Wearing a mask, they entered the room and spread another can of neutralizer on the spill. Maintenance stated that a leak in ed was noted coming through the ceiling tile. A pt and spouse were immediately moved to another room. Fire dept arrived on scene to clean up hazardous materials. Both were taped closed. An outside hazardous waste management service was brought in the clean up the rooms, ceiling tile removed and properly stored. Both rooms were certified to be used once again.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 493178 |
| MDR Report Key | 493178 |
| Date Received | 2003-10-31 |
| Date of Report | 2003-10-28 |
| Date of Event | 2003-10-22 |
| Date Facility Aware | 2003-10-22 |
| Report Date | 2003-10-28 |
| Date Reported to FDA | 2003-10-28 |
| Date Reported to Mfgr | 2003-10-28 |
| Date Added to Maude | 2003-11-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FORMALIN 10% 5 GALLON |
| Generic Name | PRESERVATIVE |
| Product Code | IFP |
| Date Received | 2003-10-31 |
| Model Number | * |
| Catalog Number | 575A-5 GAL |
| Lot Number | * |
| ID Number | ITEM# NS7129 |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 481880 |
| Manufacturer | MEDICAL CHEMICAL CORP |
| Manufacturer Address | 19430 VAN NESS AVE TORRANCE CA 90501 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-10-31 |